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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03038802




Registration number
NCT03038802
Ethics application status
Date submitted
30/01/2017
Date registered
1/02/2017
Date last updated
19/04/2021

Titles & IDs
Public title
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
Scientific title
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
Secondary ID [1] 0 0
HBV003
Universal Trial Number (UTN)
Trial acronym
HBV003
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis b 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Therapeutic hepatitis B vaccine
Other interventions - Commercial Hepatitis B vaccine

Active Comparator: Standard vaccine - Subjects will receive regular intramuscular injections of a commercial hepatitis B vaccine (HBsAg containing aluminium hydroxide adjuvant) according to the same study schedule as the subjects in the experimental arm

Experimental: Experimental therapeutic vaccine - Subjects will receive regular intramuscular injections of the experimental therapeutic hepatitis B vaccine (preS HBsAg containing Advax-2 adjuvant) in two cycles with the first cycle of four immunisations administered on days 0, 14, 28, 42. and the second cycle of four immunisations on days 70, 84, 98, and 112.


Other interventions: Therapeutic hepatitis B vaccine
HBV vaccine based on unique combination of recombinant PreS hepatitis B surface antigen particles formulated with Advax-2 adjuvant

Other interventions: Commercial Hepatitis B vaccine
Commercially available prophylactic hepatitis B vaccine formulated with alum adjuvant

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety assessment: Frequency of vaccine-related adverse events relative to active comparator vaccine - Frequency of vaccine-related adverse events relative to active comparator vaccine
Timepoint [1] 0 0
12 months post immunisation
Primary outcome [2] 0 0
Viral load - Suppression of HBV viral load
Timepoint [2] 0 0
1 and 12 months post final immunisation
Secondary outcome [1] 0 0
Seroconversion - Seroconversion to e antigen (if anti HBe negative at baseline) and seroconversion to surface antigen
Timepoint [1] 0 0
1 and 12 months post final immunisation
Secondary outcome [2] 0 0
T-cell response - Development of memory T-cell responses to HBV
Timepoint [2] 0 0
1 and 12 months post final immunisation
Secondary outcome [3] 0 0
B cell response - Development of memory B-cell responses to HBV
Timepoint [3] 0 0
1 and 12 months post final immunisation

Eligibility
Key inclusion criteria
- Male or female

- 18 years of age or older

- Current evidence of HBV chronic infection (with or without cirrhosis) as indicated by
detection of HBsAg and/or Hepatitis B DNA (Subjects on current nucleoside therapy may
have no detectable Hep B DNA)

- If child bearing age, using contraception (barrier method, IUD or oral contraception)

- Able to provide written informed consent

- Willing and able to comply with the protocol for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Positive for antibody to hepatitis B core antigen (anti-HBc) IgM with negative results
for the rest of the HBV markers, indicating acute infection,

- Positive for anti-delta virus, or anti-hepatitis C virus or HIV

- Childs Pugh Score for Cirrhosis Mortality of Child grade B or greater

- Liver transaminases greater than 5 times the upper limit of normal

- History of severe allergic reaction to hepatitis B vaccine.

- Pregnancy or female of child-bearing age not using effective method of contraception.

- Presence of any other organ-specific disease that in the opinion of the investigator
may result in risk to the subject from involvement in the study

- Current alcohol or drug abuse that in the opinion of the investigator may result in
non-compliance.

- Participation in another clinical trial with an investigational agent within 30 days
preceding initiation of treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders University - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vaxine Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Flinders University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian Respiratory and Sleep Medicine Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B
virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV
infection. An ongoing human clinical trial of this HBV vaccine in a prophylactic setting has
confirmed this vaccine to be more effective at inducing seroconversion as measured by
development of Hepatitis B surface antibody (HBsAb) in poor responder subjects than the
standard alum-adjuvanted HBV vaccine, providing promise that this new vaccine may also be
able to induce HBV viral control and/or seroconversion in chronically infected subjects
Trial website
https://clinicaltrials.gov/show/NCT03038802
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kate Muller
Address 0 0
Flinders University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kathrina Bartolay, RN
Address 0 0
Country 0 0
Phone 0 0
0882044572
Fax 0 0
Email 0 0
kathrina.bartolay@sa.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03038802